A Phase 1 interventional study of sa-mRNA vaccine Dose 1 and sa-mRNA vaccine Dose 2 in Influenza, Human, sponsored by Seqirus. Completed at 2 sites in Australia. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Seqirus (part of CSL Limited) · Phase 1, Interventional, and Prevention
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.
Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.
The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).
2,265 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 96 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Seqirus is the lead sponsor of 53 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 10 (67%) have results posted.
First submitted after Seqirus became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Biological: sa-mRNA vaccine Dose 1
Biological: sa-mRNA vaccine Dose 2
Biological: sa-mRNA vaccine Dose 3
Biological: Placebo
self-amplifying mRNA vaccine
self-amplifying mRNA vaccine
self-amplifying mRNA vaccine
Saline for injection
Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions
Time frame: up to 60 minutes or within 6 hours post vaccination
Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs
Time frame: Day 1 to Day 14 of each post vaccination period
Number and percentage of subjects reporting unsolicited AEs
Time frame: Day 1 to Day 43
Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs).
Time frame: Day 1 to Day 202
Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values
Time frame: Day 3 to Day 43
Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments
Time frame: Day 3 to Day 43
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Time frame: Day 1, Day 22, Day 43
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ])
Time frame: Day 1, Day 22, Day 43
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
Time frame: Day 1, Day 22, Day 43
Seroconversion rate (SCR) by HAI assay
SCR defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination
Time frame: Day 1, Day 22, Day 43
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
Time frame: Day 1, Day 202
Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer
Time frame: Day 1, Day 202
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ)
Time frame: Day 202
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
Time frame: Day 202
Seroconversion rate (SCR) by HAI assay
Time frame: Day 1, Day 202
Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay
Time frame: Day 1, Day 22, Day 43, Day 202
Number and percentage of subjects with ≥4-fold increase in post-vaccination ELLA titer
Time frame: Day 1, Day 22, Day 43, Day 202
Plan to share: Yes — SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).
Supporting information: Study protocol, Statistical analysis plan
Time frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
Access criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.
Data sharing details ↗ · www.seqirus.us
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Oct 2024, 12 months.
Of 84 industry-sponsored phase 1 interventional studies under Influenza, Human, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 12 months is above that.
Counting every sponsor, half of 139 studies reached it within 11 months; a quarter within 4 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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